FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
12193–12216 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 16, 1991
XEMEX TEMPORARY PACING CATHETER A
K904868 · LDF
Zeon Medical Corp.
Cardiovascular · 199d
Cleared May 16, 1991
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
K905824 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 136d
Cleared May 16, 1991
RMI VASCULAR TOURNIQUET KIT
K910221 · DXC
Research Medical, Inc.
Cardiovascular · 119d
Cleared May 16, 1991
WARMAIR SYSTEM
K910327 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 111d
Cleared May 16, 1991
CORDIS PEEL-AWAY INSERTION TOOL
K910688 · DYB
Cordis Corp.
Cardiovascular · 86d
Cleared May 16, 1991
MODIFIED PYROGEN TESTING
K910935 · DTM
Electromedics, Inc.
Cardiovascular · 91d
Cleared May 16, 1991
TORQUE DEVICE FOR A GUIDE WIRE
K910969 · DQX
Terumo Corp.
Cardiovascular · 71d
Cleared May 16, 1991
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
K911122 · DXY
Intermedics, Inc.
Cardiovascular · 65d
Cleared May 13, 1991
INTRAVASCULAR IMAGING SYSTEM/MODIFIED
K910281 · JOP
Intertherapy, Inc.
Cardiovascular · 110d
Cleared May 08, 1991
ROBICSEK PROBE/RETRACTOR
K910682 · DWP
Bio-Vascular, Inc.
Cardiovascular · 78d
Cleared May 08, 1991
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754 · LDD
Hewlett-Packard Co.
Cardiovascular · 86d
Cleared May 08, 1991
PROPAQ 102EL, 104EL AND 106EL
K910882 · DRT
Protocol Systems, Inc.
Cardiovascular · 68d
Cleared May 08, 1991
INFLATE-A-CUFF #7014
K910903 · DXQ
Pa Medical Corp.
Cardiovascular · 64d
Cleared May 07, 1991
TRIOS 02
K905087 · DXY
Biotronik, GmbH & Co.
Cardiovascular · 175d
Cleared May 07, 1991
A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER
K905114 · JOM
Research Consultants, Inc.
Cardiovascular · 175d
Cleared May 07, 1991
OSCOR MEDICAL CORP. PERMANENT PACING PAD
K905182 · DTB
Oscor Medical Corp.
Cardiovascular · 169d
Cleared May 07, 1991
PERMANENT PACING LEAD
K905300 · DTB
Oscor Medical Corp.
Cardiovascular · 161d
Cleared May 07, 1991
CARD GUARD-3000 ECG TELEPHONE ADAPTER
K910450 · DXH
Medtech Industries, Inc.
Cardiovascular · 95d
Cleared May 07, 1991
MODEL 5311B A-V PACING SYSTEM ANALYZER
K910595 · DTC
Medtronic Vascular
Cardiovascular · 84d
Cleared May 07, 1991
CARDIOCAP DR-124 RECORDER
K910620 · DRG
Datex Division Instrumentarium Corp.
Cardiovascular · 84d
Cleared May 07, 1991
DISPOSABLE PATIENT CABLE
K910645 · DSA
Diag Corp.
Cardiovascular · 83d
Cleared May 07, 1991
PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK
K910861 · DYB
Daig Corp.
Cardiovascular · 81d
Cleared May 07, 1991
BARD(R) ENDOCARDIAL BALLOON ARRAY
K911140 · DRF
C.R. Bard, Inc.
Cardiovascular · 54d
Cleared May 02, 1991
MODEL 205 SHOCK-TRODE
K910661 · DRO
Cardiotronics, Inc.
Cardiovascular · 78d